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The CryptoART Study: Decreasing Mortality Associated With Initiation of Antiretroviral Therapy in Sub-Saharan Africa Through Early Detection and Prevention of Cryptococcal Disease
The study will determine if the initiation of a 'screen and treat' program for cryptococcal disease among HIV positive individuals decreases morbidity and mortality among individuals with CD4 count \< 100 cells/mm3. The study will screen individuals who are asymptomatic for CM and are either ART naïve or ART experienced with CD4 count \< 100 cells/mm3. The introduction of an cheap, easy to use point of care diagnostic test the lateral flow assay will facilitate rapid diagnosis of cryptococcal disease in resource limited settings. The investigators will determine the efficacy of the lateral flow assay in identifying latent and asymptomatic cryptococcal disease. The investigators will determine the efficacy of the test in detecting disease in readily available body fluids such as urine and whole blood obtained via finger-stick method. The investigators will also determine the cost effectiveness of a screen and treat approach for cryptococcal disease in Zimbabwe. The investigators also wish to understand why some individuals with low CD4 counts reactivate cryptococcal disease and screen positive for cryptococcal antigen (CrAg) while others with similar levels of immunocompromised do not.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Parirenyatwa Hospital
Harare, Zimbabwe
Start Date
April 1, 2015
Primary Completion Date
June 1, 2017
Completion Date
June 1, 2017
Last Updated
October 12, 2018
1,333
ACTUAL participants
Pre-emptive screening and treatment for cryptococcal disease
OTHER
Lead Sponsor
University of Zimbabwe
Collaborators
NCT05685641
NCT01802385
Data Source & Attribution
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